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Diss Factsheets
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EC number: 212-343-5 | CAS number: 793-19-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-01-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Limited documentation in report summary but study conducted in a consistent manner with SPL Standard Test method 569.05
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: SPL Standard Test Method 569.05
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Five enucleated eyes, obtained from the New Zealand White strain of rabbit were maintained at a termperature of 32 deg C +/- 1.5 deg C within a superfusion apparatus. 0.1 mL of the test material was applied onto the cornea of each of three enucleated eyes using the REET method. The direct effect of the test material was assessment by evaluating corneal thickness, corneal opacity, alteration of corneal epithelium, and fluorescein uptake after 60, 120, 180, and 140 minutes post dosing. These were rated using an attached scoring system.
- GLP compliance:
- not specified
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.
Test material
- Reference substance name:
- Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate
- EC Number:
- 212-343-5
- EC Name:
- Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Cas Number:
- 793-19-1
- Molecular formula:
- C15H21NO4
- IUPAC Name:
- methyl 3-[benzyl(3-methoxy-3-oxopropyl)amino]propanoate
- Details on test material:
- - Name of test material (as cited in study report): T723
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): Not applicable
- Water (e.g. ad libitum): Not applicable
- Acclimation period: Not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 32 +-1.5 deg C
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): No data
VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data - Duration of treatment / exposure:
- Observations made at 60, 120, 180 and 240 minutes post dosing.
- Observation period (in vivo):
- 60, 120, 180, 240 minutes post dosing
- Number of animals or in vitro replicates:
- five enucleated eyes for testing the substance; two enucleated eyes for the control (saline solution (0.9 % sodium chloride)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
SCORING SYSTEM:
Cornea cloudiness was graded as follows:
0 = Normal cornea
1 = Some loss of transparency
2 = Moderate loss of transparency. In addition to involving the anterior stroma, the cloudiness extends all the way to the endothelium. The stroma has lost its marble-like appearance and is homogeneously white. With diffuse illumination, underlying structures are clearly visible.
3 = Involvment of the entire thickness of the stroma. With optical section, the endothelial surface is still visible. However with diffuse illumination the underlying structures are just visible.
4 = Involvment of the entire thickness of the stroma. With optical section, the endothelial surface cannot clearly visualise the endothelium. With diffuse illumination, the underlying structures cannot be seen.
The surface of the cornea relative to the area of cloudiness is divided into five grades from 0 to 4.
0 = Normal cornea with no area of cloudiness
1 = 1 to 25% area of stromal cloudiness
2 = 26 to 50% area of stromal cloudiness
3 = 51 to 75% area of stromal cloudiness
4 = 76 to 100% area of stromal cloudiness
TOOL USED TO ASSESS SCORE: fluorescein
0 = Absence of fluoresence staining
1 = Slight fluorescein staining confined to a small focus. With diffuse illumination the underlying structures are clearly visible, although there is some loss of detail.
2 = Moderate fluorescein staining confined to a small focus. With diffuse illumination the underlying structures are clearly visible, although there is some loss of detail.
3 = Marked fluorescein staining. Staining may involve a larger portion of the cornea. With diffuse illumination the underlying structures are barely visible but are not completely obliterated.
4 = Extreme fluorescein staining. With diffuse illumination the underlying structures cannot be seen.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1 / mean of 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- 60 min post dosing
- Run / experiment:
- 1 / mean of 3 eyes
- Value:
- 9
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- 120 min post dosing
- Run / experiment:
- 1 / mean of 3 eyes
- Value:
- 11.3
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- 240 min post dosing
- Run / experiment:
- 1 / mean of 3 eyes
- Value:
- 12.1
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- other: fluorescein uptake
- Remarks:
- 240 min post dosing
- Run / experiment:
- 1 / mean of 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- Croneal epithelium corneal condition was norma al all time points for all test item treated eyes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following the assessment of the data for all endpoints, the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
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